NCT04520113

Brief Summary

The purpose of this study is to characterize the role of human mobility in fueling TB epidemics and estimate the potential impact of innovative case finding interventions tailored to mobile populations

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,579

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

August 7, 2020

Results QC Date

November 26, 2024

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm

    The mean number of secondary TB cases identified and started on treatment per index case for each arm.

    Up to 35 months

Secondary Outcomes (7)

  • The TB Prevalence Ratio, Comparing Highly Mobile to Less Mobile Index Patients

    Duration of study (30 months)

  • TB Strain Relatedness Using Maximum Likelihood Transmission Trees.

    Duration of study (30 months)

  • Relative Acceptability of Each Novel Strategy Compared to Standard Contact Investigation

    Duration of study (30 months)

  • Feasibility of Each Strategy: Proportion of Potentially Eligible Index Cases for Whom a Household Visit Was Conducted

    Duration of study (30 months(

  • Relative Fidelity of Each Novel Strategy Compared to Standard Contact Investigation

    Duration of study (30 months)

  • +2 more secondary outcomes

Study Arms (3)

Standard Tracing

ACTIVE COMPARATOR

Households of tuberculosis index patients receive "standard" household contact tracing during regular weekday business hours.

Behavioral: Household contact tracing

Holiday Tracing

EXPERIMENTAL

Households of tuberculosis index patients in rural South Africa receive household contact tracing during holidays (Christmas and Easter).

Behavioral: Household contact tracing

Evening / Weekend Tracing

EXPERIMENTAL

Households of tuberculosis index patients in urban South Africa receive household contact tracing during evenings and weekends.

Behavioral: Household contact tracing

Interventions

Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.

Evening / Weekend TracingHoliday TracingStandard Tracing

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 0-99 years (Including those recently deceased)
  • Diagnosed with pulmonary TB at a study hospital or clinic (microbiological and/or chest x-ray diagnosis)

You may not qualify if:

  • Unwilling/unable to provide informed consent (including next of kin, for those recently deceased)
  • Plan not to pursue TB treatment within the study district
  • Unwilling/unable to comply with study procedures
  • Contacts:
  • Age 0-99 years
  • Currently resides with or visiting eligible TB index case
  • Unwilling/unable to provide informed consent
  • Unwilling/unable to comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Perinatal HIV Research Unit (PHRU)

Johannesburg, South Africa

Location

Setshaba Research Centre

Soshanguve, South Africa

Location

Related Publications (3)

  • Hanrahan CF, Nonyane BAS, Biche P, Mohlamonyane M, Morolo M, Omar SV, Ahmed K, Martinson N, Dowdy DW. Timing of household contact investigation for tuberculosis among rural and urban populations in South Africa (Kharituwe study): a pragmatic individually randomized controlled trial. EClinicalMedicine. 2026 Jan 16;91:103744. doi: 10.1016/j.eclinm.2025.103744. eCollection 2026 Jan.

  • Young N, Biche P, Mohlamonyane M, Morolo M, Maholwana B, Ahmed K, Martinson N, Hanrahan CF, Dowdy DW. Innovative timing strategies for tuberculosis household contact investigation: cost-effectiveness analysis from a randomized trial in rural and urban South Africa (Kharituwe Study). EClinicalMedicine. 2025 May 26;84:103259. doi: 10.1016/j.eclinm.2025.103259. eCollection 2025 Jun.

  • Mlambo LM, Milovanovic M, Hanrahan CF, Motsomi KW, Morolo MT, Mohlamonyane MP, Albaugh NW, Ahmed K, Martinson NA, Dowdy DW, West NS. The impact of ethical implications intertwined with tuberculosis household contact investigation: a qualitative study. medRxiv [Preprint]. 2024 Jun 28:2024.06.27.24309538. doi: 10.1101/2024.06.27.24309538.

MeSH Terms

Conditions

TuberculosisAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Dr. Colleen Hanrahan
Organization
Johns Hopkins Bloomberg School of Public Health

Study Officials

  • David W. Dowdy, MD, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The principal investigators are blinded as to the assignment of treatment to participants
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 20, 2020

Study Start

September 1, 2020

Primary Completion

August 30, 2023

Study Completion

March 31, 2025

Last Updated

April 8, 2025

Results First Posted

February 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations